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Male self catherterisng observational study.
This is a multicentre, prospective international observational study. Male patients in the UK, USA and France performing self-catheterisation will be asked to participate in this study. The subjects will be asked to use the GentleCathâ„¢ Intermittent Catheter with FeelCleanâ„¢ Technology as per their normal routine. They will be asked to record when and where they catheterise. At the baseline, during and on completion of the study, the subjects will be asked to complete Difficulty in Catheterisation plus Intermittent Catheter related Quality of Life Questionnaires.
Difficulty during catheterisation and quality of life will be assessed using the ICDQ and ISC-Q validated questionnaires during catheterisation at the start of the study before use of GentleCathâ„¢ Air has commenced (D0) and on day 1 (D1), day 15 (D15), day 30 (D30), day 45 (D45) and day 60 (D60) transcribed in a collecting record provided for this purpose. Compliance and catheter use will also be assessed.
Patient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection will also be recorded.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent self-catheterisation | Device | Self-catheterising with GC Male and Glide Male with Feelclean technology |
| Measure | Description | Time Frame |
|---|---|---|
| To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q validated questionnaires during catheterisation | To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess patient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection | To assess patient confidence regarding reduced stickiness plus related risk of urethral | 60 days |
| To assess compliance with the self-catheterization for the study duration |
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Inclusion Criteria:
• Adult male (aged 18 years and over)
Exclusion Criteria:
• Participation in another related urological study
Must be able to insert catheter into a penile urethra
Adult males who self-catheterise
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| Name | Affiliation | Role |
|---|---|---|
| Chris Harding | Site Investigator - Newcastle | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Institute for Rehabilitation | West Orange | New Jersey | 07052 | United States | ||
| Trustees of The University of Pennsylvania | Penn Urology Washington Square |
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To assess compliance with the self-catheterization for the study duration |
| 60 days |
| Philadelphia |
| Pennsylvania |
| 19106 |
| United States |
| Centre Hospitalier Universitaire de Bordeaux | Pellegrin Hospital - Urology Department | Bordeaux | 33076 | France |
| Assistance Publique Hopitaux de Paris | Pitie Salpetriere University Hospital - Urology Department | Paris | 75013 | France |
| Stockport NHS Foundation Trust | Stepping Hill Hospital - Research and Innovation Department | Stockport | Cheshire | SK2 7JE | United Kingdom |
| Broomfield Hospital | Chelmsford | Essex | CM1 7ET | United Kingdom |
| Mid and South Essex NHS Foundation Trust | Southend University Hospital - Research & Development | Southend-on-Sea | Essex | SS0 0RY | United Kingdom |
| Aneurin Bevan University Health Board | Royal Gwent Hospital - Clinical Research Centre | Newport | Gwent | NP20 2UB | United Kingdom |
| Southampton General Hospital | Southampton | Hampshire | SO16 6YD | United Kingdom |
| Kent and Canterbury Hospital | Renal Research Delivery Team | Canterbury | Kent | CT2 7FG | United Kingdom |
| Newcastle upon Tyne Hospitals NHS Foundation Trust | Freeman Hospital - Urology Department | Newcastle | Newcastle Upon Tyne | NE7 7DN | United Kingdom |
| Sunderland Royal Hospital | Sunderland | Tyne & Wear | SR4 7TP | United Kingdom |
| North Bristol NHS Trust | Southmead Hospital - Research and Development - Urology Department | Bristol | Westbury-on-Trym | BS10 5NB | United Kingdom |
| Mid Yorkshire Teaching NHS Trust | Pinderfields Hospital - Yorkshire Regional Spinal Injuries Centre | Wakefield | Yorkshire | WF1 4DG | United Kingdom |
| Guy's and St Thomas' Foundation Trust | Guy's Hospital - Transplant, Renal and Urology Research | London | SE1 9RT | United Kingdom |
| King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department | London | SE5 9RS | United Kingdom |
| ID | Term |
|---|---|
| D001748 | Urinary Bladder Neck Obstruction |
| D009103 | Multiple Sclerosis |
| D000077684 | Cauda Equina Syndrome |
| D010300 | Parkinson Disease |
| D059411 | Lower Urinary Tract Symptoms |
| D000077295 | Urinary Bladder, Underactive |
| D013119 | Spinal Cord Injuries |
| D001750 | Urinary Bladder, Neurogenic |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D052801 | Male Urogenital Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009408 | Nerve Compression Syndromes |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D011129 | Polyradiculoneuropathy |
| D011115 | Polyneuropathies |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
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